Polysorb UL-215Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521049512), received between Oct 22, 2018 and Oct 25, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE WAS BROKEN WHILE SUTURING. THE SCREW DAMAGED THE NEEDLE AWAY. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533229 ↗
• MalfunctionNov 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE CAME OFF THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 15752721 ↗
• MalfunctionApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN LAPAROSCOPIC ANASTOMOSIS PROCEDURE, THE DOCTOR INFORMED THAT THE PATIENT HAD A LEAK THAT RESULTED IN A STRICTURE.

  Patient problems: Stenosis

  MAUDE report 14164663 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC PROCEDURE, THE PATIENT HAD AN ANASTOMOTIC LEAK THAT RESULTED IN A STRICTURE. THE DOCTOR INFORMED THE REPORTER THAT THERE COULD BE AN IMPAIRMENT FOR LIFE FOR THE PATIENT. A RE-OPERATION WAS REQUIRED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 14108778 ↗
• MalfunctionOct 9, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE SUTURING, THE THREAD BROKE FROM THE SUTURE. ANOTHER SUTURE WAS OPENED THE SAME ISSUE OCCURRED. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10659230 ↗
• InjuryOct 22, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGERY IN THE EARS, NOSE AND/OR THROAT, THE NEEDLE BROKE OFF AND FELL IN THE TISSUE AND COULD NOT BE FOUND. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, OR CONFIRM THAT ALL PIECES WERE LOCATED. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THERE WAS A SLIGHT UNNECESSARY DAMAGE TO THE TISSUE. THEY HAD TO USE AN ULTRASOUND TO FIND AND RETRIEVE THE NEEDLE.

  Patient problems: No Code Available; Radiation Exposure, Unintended; Tissue Damage

  MAUDE report 7990900 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI